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The FDA approved Impax Labs’ Parkinson’s disease drug Rytary after the drugmaker agreed to not use a troubled manufacturing facility for production. Read More
China’s FDA is pledging to impose stronger drug safety regulations, with efforts focused on risk assessments and a risk grading and classification system, as well as initiatives to effectively detect and solve problems. Read More
Drug sponsors are expected to expand their investments in developing new cancer therapies this year, spurred by a growing understanding of tumors’ molecular bases and immunotherapy techniques, according to a new report that projects pharma and biotech trends for 2015. Read More
An FDA advisory committee may have given its unanimous approval for a biosimilar application this week, but industry and patient groups contend the regulatory pathway still has many potholes, including unanswered questions on naming, labeling, testing requirements and interchangeability of the products. Read More
European Medicines Agency advisors have recommended approval of Newron and Zambon Pharmaceuticals’ Parkinson’s disease drug Xadago in combination with levodopa or other therapies for mid- to late-stage patients experiencing motor fluctuations. Read More
The UK’s healthcare cost watchdog has updated its methods for reviewing biosimilar applications in anticipation of the products’ increasing availability in the country. Read More
An Indian clinical trial advisory body has recommended exempting some drugs, including those to treat cancer and hepatitis C, from a requirement that manufacturers conduct local Phase III trials as a condition of marketing approval. Read More
Drugmakers could end up paying millions of dollars on collection and disposal programs for unwanted drugs nationwide if industry groups aren’t able to stop a California county ordinance. Read More